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NCT05219695 · ClinicalTrials.gov registry record · NA
Medical Imaging and Thermal Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI)
A NA study of Breast Cancer Stage I and Fibroadenoma, sponsored by Columbia University.
- Recruiting
- Registry status
- NA
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT05219695: Recruiting NA study of Breast Cancer Stage I and Fibroadenoma, sponsored by Columbia University.
NCT05219695 is a NA study of Breast Cancer Stage I and Fibroadenoma that is actively recruiting participants, run by Columbia University. The registered enrollment target is 36 participants, below the 164-participant average among 18 other Breast Cancer Stage I trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05219695, a NA study of Breast Cancer Stage I and Fibroadenoma, is actively recruiting participants, sponsored by Columbia University.
- RECRUITING
- Registry status
- NA
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this study is to demonstrate the initial clinical feasibility of using Harmonic Motion Imaging (HMI) for Focused Ultrasound Surgery (FUS) guidance and monitoring in patients with benign and stage 1 non-metastatic breast cancers. The investigators hypothesize that changes in HMI parameters will inform progression of FUS ablation.
Primary Outcome
To identify markers of ablation progression using HMIgFUS images, thereby predicting whether ablation occurred or not. The investigators will also use differences in HMI imaging performed before and after ablation to assess the presence of ablation. The results from both of these methods will be validated with pathological findings, to determine whether ablation was achieved.
Conditions Studied
Interventions
- PROCEDURE Harmonic motion imaging guided focused ultrasound (HMIgFUS)
Study Locations (1)
New York
- Columbia University Irving Medical Center/NYP - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2022-01-19 |
| Est. Completion | 2026-05 |
| Phase | NA |
What NCT05219695 shows while recruiting
NCT05219695 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 164-participant average among 18 other Breast Cancer Stage I trials with a reported enrollment target (78% lower).
The record links to 2 conditions, with Breast Cancer Stage I appearing as the primary indexed condition, and to 1 intervention - of which Harmonic motion imaging guided focused ultrasound (HMIgFUS) is the first listed.
NCT05219695 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05219695 about?
NCT05219695 is a clinical study titled "Medical Imaging and Thermal Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI)". The objective of this study is to demonstrate the initial clinical feasibility of using Harmonic Motion Imaging (HMI) for Focused Ultrasound Surgery (FUS) guidance and monitoring in patients with benign and stage 1 non-metastatic breast cancers. The investigators hypothesize that changes in HMI para...
What is the current status of trial NCT05219695?
This trial is currently recruiting. It is a NA study. The enrollment target is 36 participants. The study started on 2022-01-19. Estimated completion is 2026-05.
What conditions does trial NCT05219695 study?
This clinical trial studies the following conditions: Breast Cancer Stage I, Fibroadenoma.
What interventions are being tested in trial NCT05219695?
The interventions under investigation include: Harmonic motion imaging guided focused ultrasound (HMIgFUS) (PROCEDURE).
Who is sponsoring clinical trial NCT05219695?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05219695 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer Stage I
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05219695's enrollment target sits among peer trials
36 14th of 18 higher than 5 of 18 other Breast Cancer Stage I trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer Stage I trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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